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Detection of Salmonella species in a Variety of Foods by the DuPont™ BAX® System Real-Time
PCR Assay for Salmonella – ERP Reviews
I.
TECHNICAL EVALUATION CRITERIA:
a.
General Comments about the Method Scope/Applicability:
Reviewer 1 (Achen):
The method scope is broad and includes a range of matrices (meat and non-meat) and
environmental surfaces.
Reviewer 2 (Douey):
DuPont is recommending that the method be adopted as Official First Action status for the
detection of Salmonella in all 24 food and environmental matrices tested. Will a method
will be published with conditions (which vary) for each of the 24 foods and/ environmental
matrices. The PTM did not always give full details of incubation (eg., how much broth to add
during enrichment).
Reviewer 3 (Hitchins):
In PTM and pre-collaborative studies the method has been tested and approved for 24
matrices including meat and poultry products, dairy products, seafood, vegetable and fruit
produce and miscellaneous food products as well as 3 types of food processing related
surfaces. These matrices fairly represent those that are most commonly involved in food
related occurrences of Salmonella. Orange juice and frankfurters were selected from this
selection of matrices for this collaborative study.
Reviewer 4 (Brodsky):
Clearly stated and accurate based on the data provided.
Reviewer 5 (Hammack):
The official method applicability statement (page 4, lines 7-11) must include the fat content
of the ground beef, the type of frankfurters (beef, chicken, turkey, etc.), dried eggs (whole?),
nonfat dry milk (instant or non-instant?), ice cream (fat content?), infant formula (casein or
soy).
Reviewer 6 (Hayes - Safety):
N/A
Reviewer 7 (Fernandez):
N/A
Reviewer 8 (Chen):
Do we need to evaluate the claims and package insert?